SYNTap™ Biomarker Test FAQs

Frequently Asked Questions About the SYNTap Test.

What’s the SYNTap Biomarker Test?

The SYNTap Test is a qualitative test. It can be used to rule in or rule out synuclein pathology. The test amplifies misfolded α-synuclein aggregates and can detect even minute levels in cerebrospinal fluid (CSF).

Detection of misfolded α-synuclein in CSF is consistent with the presence of active synucleinopathies such as Parkinson’s Disease (PD) or Lewy Body Dementia (LBD).  Synucleinopathies can also be present as an underlying pathology that complicates the effective management of other diseases, including Alzheimer’s.

Who performs the SYNTap Test?

The SYNTap Test is performed exclusively at Amprion’s CLIA-registered laboratory in San Diego.

Who should take the SYNTap Test?

The SYNTap Test is a clinical biomarker test and must be ordered by a physician. Along with other clinical and diagnostic findings, doctors can use our test results to help guide patient care and management.

Amprion’s test benefits patients exhibiting signs and symptoms of a potential synucleinopathy such as:

  • Parkinson’s Disease (PD or atypical Parkinson’s)
  • Lewy Body Dementia (or Dementia with Lewy Bodies, LBD)
  • Alzheimer’s Disease (AD)
  • Mild Cognitive Impairment (MCI)
  • Multi-system Atrophy (MSA)

Or, as we like to call the above – the ParkinZheimer spectrum diseases.

In blinded research studies, the SYNTap Test has been shown to:

  • Detect aggregates of misfolded α-synuclein years before symptoms of synucleinopathy appear.
  • Detect aggregates in patients diagnosed with other neurodegenerative diseases, such as Alzheimer’s Disease, who may not show signs of Lewy body disease.

Results from these studies have been submitted to peer-review journals and will be posted upon acceptance.

Where is SYNTap Test available?

The test is currently available in the US, except Maryland, New York, Pennsylvania, and Rhode Island. We are working hard to complete the rollout in these states as soon as possible.

FDA Breakthrough Device Designation

The USA FDA awarded Amprion’s SYNTap Test a Breakthrough Device Designation for detecting misfolded α-synuclein aggregates in patients undergoing evaluation for Parkinson’s Disease (PD). Amprion will be seeking FDA approval for the SYNTap Test.

This FDA designation is given to medical devices with the following qualifications:

  • Provide effective diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.
  • Offer a service when no approved or cleared alternatives to exist.
  • Represent significant advantages over approved alternatives, and/or its availability is in the best interest of the patients.

How the SYNTap Test works

The SYNTap Biomarker Test is performed using Amprion’s proprietary Prion Detection Science℠, called Seed Amplification Assay (SAA). It mimics the biological process by which proteins misfold and aggregate.

  • If aggregates are formed in the reaction, they are detected using an amyloid-specific fluorescence binding probe.
  • If the sample has no endogenous aggregates, amplification does not occur, and fluorescence remains below the detection cutoff.

The accuracy of the SYNTap Test was evaluated against CSF samples from patients with a clinical diagnosis of PD or LBD and control patients with no known neurological disease.

Research studies show misdiagnosis of PD and LBD occurs over 20% of the time. The SYNTap Test has proven to confirm patients with synucleinopathy and rule out those who do not currently have the underlying pathology. Thus, the SYNTap Biomarker Test provides physicians a valuable tool empowering accurate diagnosis.

References:

J Neurol Neurosurg Psychiatry. 2018 Apr;89(4):358-366. doi: 10.1136/jnnp-2017-316844. Epub 2017 Oct 13. Accuracy of clinical diagnosis of dementia with Lewy bodies: a systematic review and meta-analysis

Neurology. 2016 Feb 9;86(6):566-76. doi: 10.1212/WNL.0000000000002350. Epub 2016 Jan 13. Accuracy of clinical diagnosis of Parkinson disease: A systematic review and meta-analysis

Result report

Amprion will provide the SYNTap Test lab result report to the prescribing healthcare provider within 15 business days of receiving samples.

Healthcare providers can select the preferred report shipment method on the test order form. Options include:

  • Secure FAX
  • Encrypted email, or
  • US mail

Click to see the sample report for DETECTED or NOT-DETECTED.

Does a “Not Detected” test result means my patient will not develop a synucleinopathy in the future?

A “Not Detected” SYNTap Test result does not mean that a patient will not develop a synucleinopathy in the future.

A patient’s disease may change or evolve; if you continue to suspect a synucleinopathy in the patient, you can re-order a test. We suggest waiting for at least 12-months.

Detection limit 

Amprion has determined the SYNTap Test detection limit to be ~44 femtograms/mL, using alpha-synuclein aggregates as a proxy.

Do any substances interfere with the SYNTap Test?

No interference was seen when conjugated bilirubin, hemoglobin, albumin, and whole blood were spiked into CSF at levels much higher than would be expected in normal practice.

The interference of specific medications has not been formally evaluated. However, no evidence of interference has been seen in research studies using CSF samples collected from healthy donors or patients taking various prescription and over-the-counter medications.

How to order the SYNTap Test?

Fill out the Doctor’s Registration Form. A member of our team will contact you.

What are the sample requirements? 

Your office (or affiliated institution) will collect blood-free CSF according to standard institutional practices.

Sample volume

Amprion requires a 1 mL CSF sample with an acceptable minimum volume of 0.5 mL.

The submitted sample can be from any fraction (e.g., beginning, middle, or end of the draw) or tube of a blood-free CSF draw.

Sample tube

You may use your sample tube or ones provided by Amprion. Screw-top plastic cryovials or protein LoBind tubes are preferred. Sample tubes with a snap-cap may be used but should be wrapped securely to prevent leakage during shipping.

Sample storage

Samples can be frozen to -20°C or -80°C and shipped on dry ice or maybe held refrigerated and shipped with an ice pack.

Sample shipment 

Refrigerated samples should be shipped within 24 hours of collection.

Samples should be shipped via FedEx overnight express to arrive at Amprion’s laboratory during normal business hours Monday-Friday between 9 AM-5 PM PST.

***Please note: we do not accept samples arriving on Saturdays or Sundays.***

Amprion Laboratory
10355 Science Center Drive, Suite 240,
San Diego, CA 92121

Telephone: 1‑858-461-6338 (M-F 9AM – 5 PM PST)
Email: Customer.Service@AmprionMe.com

How will I receive the lab results?

Amprion will provide you with a lab report within 15 business days of receiving a CSF sample.

Please indicate on the Test Requisition Form your preferred method of receiving the lab test result:

  • Secure FAX
  • Encrypted email, or
  • US mail

Billing and Reporting

Does insurance cover the SYNTap Test?

Currently, Amprion offers this test on a self-pay basis. However, we are working diligently to establish reimbursement from private insurance providers, Medicare, or Medicaid.

How do patients pay for the test?

Your patient will receive a bill in the mail after their lab report has been sent to you. Amprion accepts credit cards and personal checks. Patients can make a payment via regular mail or over the phone.

Patient Billing Center::
Telephone: 1-858-461-6338 (M-F 9AM – 5PM PST)
Email: Patient.Services@AmprionMe.com

What if my patient cannot afford the test?

Contact our Patient Billing Center for details about payment options and our financial assistance program.

Is ABN required for Medicare patients? 

For Medicare patients, an Advance Beneficiary Notice (ABN) is required. The patient-signed ABN Form should accompany the requisition and sample when shipped.

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